NOTE TO READERS: When this project lost substantial funding at the end of 2018, I lost the ability to continue publishing criteria-driven news story reviews and PR news release reviews - once the bread-and-butter of the site going back to 2006. The 3,200 archived reviews, while still educational, are getting old and difficult for me to technically maintain on the back end of the website. So I am announcing that I plan to remove these reviews from the site by April 1, 2021. The blog and the toolkit - two of the most popular features on the site - will remain. If you wish to peruse the reviews before they disappear, please do so by the end of March 2021. After that date you may still be able to access them via the Internet Archive Wayback Machine - https://archive.org/web/.
Read Original Story

Chantix

Rating

2 Star

Chantix

Our Review Summary

This network news story discussed the benefits of the drug varenicline (trade name Chantix) for smoking cessation. Varenicline may be an option for those who have not been able to quit smoking using other drug treatments, such as the anti-depressant bupropion (trade name Zyban) or nicotine replacement therapy. The broadcast provides an incomplete explanation of how this drug differs from nicotine replacement therapy.

The story presents longer-term (1 year) abstinence rates, which are important for evaluating smoking cessation therapies, but it does not compare these numbers to the non-varenicline group. There is also no discussion of side effects. Nausea, headaches, insomnia and other stomach problems were more common in the varenicline group, but none of these are mentioned in the broadcast. More importantly, the story mentions that this drug would be useful for smokers who have high blood pressure or heart conditions; however, varenicline has not been specifically tested in people with these conditions. The clinical trials of varenicline included mainly healthy participants between age 18-65.

Varenicline is currently approved for use up to 12 weeks. Smoking addiction is considered a chronic condition, so the goal of treatment is to prevent relapse. Use of this drug beyond 12 weeks to prevent relapse may be necessary. However, continuing varenicline beyond 12 weeks would be considered an off-label use of the drug. In addition, the broadcast does not mention the current availability or cost of varenicline (which must be taken twice daily). Varenicline is currently not covered by most health insurance plans, so the cost would be out-of-pocket for many consumers.

Approval of varenicline was largely based on two double-blind, randomized studies of 2000 smokers in which the drug was compared with bupropion and a placebo. The studies were both funded by Pfizer, maker of varenicline. The recent studies referred to in this broadcast were also funded by Pfizer, which is not mentioned in the broadcast. (Pfizer is a major advertiser on the evening network news.)

Finally, the story doesn’t discuss the behavioral component of treatment and doesn’t acknowledge that long-term smoking cessation might be accomplished by a number of available therapies, and varenicline is only one option.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not mention the 12-week cost of varenicline (which must be taken twice daily). Varenicline is currently not covered by many health insurers, so the cost would be out-of-pocket for many consumers.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The story provides some quantitative evidence from recent randomized controlled trials of varenicline vs. placebo and varenicline vs. bupropion (although the story doesn’t explain that trial design and never mentions bupropion). The story appropriately notes that abstinence rates at 1 yr. were about half that at 12 weeks. The story did not, however, compare quit rates at one year to the non-varenicline group. Only relative estimates were given, no absolute figures.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

No discussion of any side effects of the drug. Nausea, headaches, insomnia and other stomach problems were common in the varenicline groups in clinical trials (about 30% of people), though, this is not mentioned in the broadcast. The story mentions that this drug would be useful for smokers who have high blood pressure or heart conditions; however, the drug has not been specifically tested in people with these conditions. The clinical trials of varenicline included healthy volunteers between age 18-65, with few co-existing health conditions.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story mentions abstinence rates at 12 and 52 weeks, but does not mention the design of the new varenicline trials. The relative numbers provided here need context: 45-50% of how many patients? What are the absolute rates? Is it 50% of 10 people or 100 people or 1,000 people?

Does the story commit disease-mongering?

Satisfactory

There does not seem to be evidence of disease mongering, however, not all people who attempt to stop smoking will need pharmaceutical treatment.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

Approval of varenicline was largely based on two double-blind, randomized studies of 2000 smokers in which the drug was compared with bupropion and a placebo. The studies were both funded by Pfizer, maker of varenicline. The recent studies referred to in this broadcast were also funded by Pfizer, which is not mentioned in the broadcast. (Pfizer is a major advertiser on the evening network news.) Also, the report did not consult independent sources for perspective on this new drug.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

This story briefly mentions nicotine replacement therapies. The story doesn’t discuss the behavioral component of treatment or that varenicline was compared with bupropion in clinical trials. When taken once a day, this drug worked nearly as well as bupropion when compared against placebo in randomized controlled studies. There is no acknowledgment in the story that long-term smoking cessation might be accomplished by a number of available therapies, and varenicline is only one option.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

Refers to story on recent FDA approval, but doesn’t explain if the drug is available in pharmacies. Many FDA-approved drugs are not on the market yet. And the broadcast does not mention that varenicline is currently approved for only 12 weeks use. The broadcast also does not mention if the drug is available in pharmacies. Smoking addiction is considered a chronic condition, so the goal of treatment is to prevent relapse. Use of this drug beyond 12 weeks (or if relapse occurs) may be necessary to help with continued smoking cessation. Continuing varenicline beyond 12 weeks would be considered off-label use of the drug.

Does the story establish the true novelty of the approach?

Satisfactory

The story is about a nicotine receptor agonist: a new drug with an old mechanism (nicotine replacement). The broadcast does an adequate, but not great job decribing the chemical action of varenicline, a chemical that acts as a mild form of nicotine. This drug differs from nicotine replacement, however. Varenicline binds to the nicotine receptor and only partially activates it so there is less stimulation than by nicotine itself. One of the downstream events from nicotine receptor binding is dopamine release in the parts of the brain wired for reward.

Does the story appear to rely solely or largely on a news release?

Not Applicable

We can’t be sure if the story relied solely or largely on a news release because we can’t be sure who or what the source was for the information. No source is named.

Total Score: 2 of 9 Satisfactory

Comments

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.